Duns Number:038000253
Device Description: 14F X 24CM 400XL IJ14F X 24CM 40 CATHETER SETCATHETER SET
Catalog Number
DDFXL149IJS
Brand Name
400XL IJ400XL IJ
Version/Model Number
DDFXL149IJS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MPB
Product Code Name
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Public Device Record Key
679861fd-e498-4a5e-a76d-81c450072d68
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
July 31, 2019
Package DI Number
50884908145323
Quantity per Package
5
Contains DI Package
00884908145328
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |